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For more information about BETHKIS® (Tobramycin Inhalation Solution), prescription support services, or other product inquiries, contact a Chiesi CareDirect® Specialist.

Contact Chiesi CareDirect

Mail:
Chiesi CareDirect
PO Box 30317
Bethesda, MD 20824-0317
 
Phone:
1-888-865-1222
 
Fax:
1-866-410-6241
 
Email:
chiesicaredirect@caremetx.com
 

Contact Chiesi USA, Inc.

Mail:
Chiesi USA, Inc.
1255 Crescent Green Drive
Suite 250
Cary, NC 27518
 
Phone:
1-888-466-6505

Request medical information

To request specific medical information about BETHKIS or to report adverse events or product complaints, contact the Medical Information Department.
 
Adverse events may also be reported to FDA’s MedWatch Program at 1-800-FDA-1088.
 
Mail:
Chiesi USA, Inc.
1255 Crescent Green Drive
Suite 250
Cary, NC 27518
 
Phone:
1-888-661-9260
 
Fax:
1-866-443-3092
 
Email:
US.Medical@chiesi.com

 

Indication

BETHKIS® (Tobramycin Inhalation Solution) is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia.

Important Safety Information

BETHKIS is contraindicated in patients with a known hypersensitivity to any aminoglycoside.

Bronchospasm can occur with inhalation of BETHKIS. Bronchospasm and wheezing should be treated as medically appropriate.

Caution should be exercised when prescribing BETHKIS to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction. Audiograms, serum concentration, and renal function should be monitored as appropriate.

Avoid concurrent and/or sequential use of BETHKIS with other drugs with neurotoxic or ototoxic potential.

BETHKIS should not be administered concurrently with ethacrynic acid, furosemide, urea, or mannitol.

Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.

Fetal harm can occur when aminoglycosides are administered to a pregnant woman. Apprise women of the potential hazard to the fetus.

Common adverse reactions (more than 5%) occurring more frequently in BETHKIS patients are forced expiratory volume decreased, rales, red blood cell sedimentation rate increased, and dysphonia.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Please see full prescribing information.

 

This website is intended for United States residents only.

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